ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Secondary Hyperparathyroidism
Intervention: Sensipar® (Drug); Vitamin D (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
Summary
The purpose of this study is to compare the proportion of chronic kidney disease (CKD)
subjects on dialysis receiving Sensipar® and low dose vitamin D or escalating doses of
vitamin D alone who are able to achieve the National Kidney Foundation-Kidney Disease
Outcomes Quality Initiative (NKF-K/DOQI) secondary hyperparathyroidism (HPT) treatment
targets for both biointact parathyroid hormone (biPTH) and calcium-phosphorus (Ca x P)
product.
Clinical Details
Official title: ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism: A Comparison of Sensipar® and Low Dose Vitamin D vs. Escalating Doses of Vitamin D Alone
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Achieving the NKF-K/DOQI targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (less than 55 mg^2/dL^2) during the assessment phase
Secondary outcome: Absolute Change from Baseline for P During the Assessment PhaseProportion of Participants with ≥ 30% Reduction from Baseline in Mean iPTH During the Assessment Phase Percent Change from Baseline for Calcium During the Assessment Phase Percent Change from Baseline for Phosphorus During the Assessment Phase Percent Change from Baseline for Ca x P During the Assessment Phase Percent Change from Baseline for iPTH During the Assessment Phase Proportion of Participants who Attained the K/DOQI Target Range for Ca x P During the Assessment Phase. Proportion of Participants who Attained the K/DOQI Target Range for Ca During the Assessment Phase Proportion of Participants who Attained the K/DOQI Target Range for iPTH During the Assessment Phase Proportion of Participants who Attained the K/DOQI Target Range for P During the Assessment Phase. Absolute Change from Baseline for iPTH During the Assessment Phase Absolute Change from Baseline for Ca During the Assessment Phase Absolute Change from Baseline for Ca x P During the Assessment Phase
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria: - On hemodialysis for at least 3 months and have received intravenous
vitamin D therapy (paricalcitol or doxercalciferol) for at least 3 months prior to
entering screening - Historical iPTH 150-800 pg/ml (or biPTH 80-430 pg/ml) within 6 months
and corrected serum Ca greater than 8. 4 mg/dl within 2 months prior to screening period.
For subjects with biPTH 80-160 pg/ml (iPTH 150-300 pg/ml), Ca x P must be greater than 55
mg²/dl² within 2 months prior to the screening period - Screening (pre-washout) biPTH
80-430 pg/ml and a corrected serum Ca level greater than 8. 4 mg/dl. For subjects with
biPTH 80-160 pg/ml Ca x P must be also greater than 55 mg²/dl² - Baseline mean biPTH
(post-washout) greater than 160 pg/ml and mean corrected Ca greater than 8. 4 mg/dl
Exclusion Criteria: - Parathyroidectomy in the 3 month period prior to screening - Current
gastrointestinal disorder that may be associated with impaired absorption of orally
administered medications or an inability to swallow tablets - Use of investigational drug
or device or participation in a trial of investigational drug or device within 30 days of
screening - Females of child bearing potential who are pregnant (e. g., positive pregnancy
test) or are breast feeding or who refuse to use highly effective contraceptive measures
(as determined by the investigator) throughout the study - Previously participated in this
or any other Sensipar® study or has received or is receiving Sensipar® as a commercially
available product
Locations and Contacts
Additional Information
AmgenTrials clinical trials website
Related publications: Fishbane S, Shapiro WB, Corry DB, Vicks SL, Roppolo M, Rappaport K, Ling X, Goodman WG, Turner S, Charytan C. Cinacalcet HCl and concurrent low-dose vitamin D improves treatment of secondary hyperparathyroidism in dialysis patients compared with vitamin D alone: the ACHIEVE study results. Clin J Am Soc Nephrol. 2008 Nov;3(6):1718-25. doi: 10.2215/CJN.01040308. Shireman TI, Almehmi A, Wetmore JB, Lu J, Pregenzer M, Quarles LD. Economic analysis of cinacalcet in combination with low-dose vitamin D versus flexible-dose vitamin D in treating secondary hyperparathyroidism in hemodialysis patients. Am J Kidney Dis. 2010 Dec;56(6):1108-16. doi: 10.1053/j.ajkd.2010.07.012. Epub 2010 Oct 15. TBD.Sensipar plus low dose vitamin D (ACHIEVE).Journal-004521; TBD.Time in target.Journal-004521;
Starting date: August 2005
Last updated: February 7, 2014
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